Many persons who are ill find it difficult to take medications that are recommended for oral administration. These include both oral medications intended to be effective locally and systemic medications taken by the oral route. The very young and the elderly, in particular, often experience difficulties swallowing orally administered systemic medications. In addition, it is also often very difficult for persons in these groups to retain pastilles, troches or lozenges in their mouths long enough for all of the medication to dissolve and produce the desired local effect.
Patients whose general condition has been weakened by a debilitating disease, radiation therapy, chemotherapy or other condition may require the administration of oral medication to treat the fungus or other infections which often accompany such conditions. One extremely common oral infection encountered in such patients is candidiasis, also known as thrush. This disease, which produces very painful lesions in the oral mucosa, can be quite virulent and even fatal, especially in the very young and elderly. The severe pain associated with oral candidiasis usually limits such patients to the ingestion of only liquids, since solid foods and medications can produce intolerable pain. The currently available forms of medication for this condition are often not well tolerated.
The prior art has suggested various approaches to the administration of oral medication as well as to the oral administration of medication producing systemic effects that are intended to facilitate the administration of such medication. For example, U.S. Pat. No. 4,725,440 to Ridgway et at. discloses an anti-fungal pastille with a soft and smooth texture intended to avoid irritation of the oral mucosa. This pastille is intended to dissolve slowly to deliver the anti-fungal agent, which is preferably Nystatin. Although this is an effective means for maintaining an effective level of medication for the treatment of oral infections, such as thrush, the pastille form of medication is not well tolerated by all patients. Very young children, in particular, often tend to spit the pastille out of the mouth before it has completely dissolved. Some elderly patients also may not be able to retain the pastille for sufficient time to be of optimum therapeutic value. Patients often feel the pastille exacerbates the dry condition of the mouth called "cotton mouth" by patients suffering from oral candidiasis.
U.S. Pat. No. 5,132,114 to Stanley et al. discloses a method for the transmucosal delivery of medication which can have local and/or systemic effect. The therapeutic agent is incorporated into a "candy" matrix in powder form and compressed to form a "lollipop" which includes a suitable holder. This medication delivery system is ideally suited for many patient populations. However, the patient must be strong enough to be able to hold the lollipop in his or her mouth to suck on it. The very young, the elderly and those whose condition has weakened them so that a lollipop cannot be held for a sustained period of time may not be able to use this medication delivery system effectively.
U.S. Pat. No. 4,238,475 to Witzel et al. discloses a chewing gum formulation that releases a small continuous dose of a medication, such as Nystatin, or an orally beneficial material into the mouth. This means of delivering medication to the mouth and oral mucosa can be very effective. However, persons with dentures or bridge work, persons with orthodontic appliances and very young children are unable to chew gum, which limits the use of this medication delivery system to that segment of the population capable of chewing gum comfortably.
U.S. Pat. No. 4,999,185 to Takemori et al. discloses a composition which inhibits sordes formation for application to the oral cavity that may be incorporated into candy, gum, cookies, chocolate milk or ice cream and formulated as a tablet, toothpaste or mouthwash. This composition, which is extracted from cacao husk, bears sufficient resemblance to chocolate to mix readily with food products. It is not suggested that other medicaments or compositions which are unpleasant to the taste could be incorporated into food products to simplify their administration to certain patient populations.
U.S. Pat. No. 4,478,822 to Haslam et al. discloses a drug delivery system which can be used to deliver drugs to, inter alia, the oral cavity. This drug delivery system uses an aqueous vehicle that includes a polymer which causes the aqueous system to form a gel at temperatures encountered in body cavities. While this drug delivery system is probably very effective for delivering medication to many body cavities, it is not likely to be the most effective method of delivering medication to the oral cavities of children.
A need exists, therefore, for a system and method for delivering oral and systemic medication to the oral cavity that (1) may be used effectively by such populations as the very young and the elderly, and (2) not only delivers the medication but provides palliative relief for the soreness and dry condition by the mouth which accompanies many disease states.